Notice2024-20064
Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
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Published
September 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collections applicable to the Pharmaceutical Distribution Supply Chain, provided for in Subchapter H of Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 89 Issue 173 (Friday, September 6, 2024)</title>
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[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Notices]
[Pages 72848-72851]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3675]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply
Chain Security
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collections
applicable to the Pharmaceutical Distribution Supply Chain, provided
for in Subchapter H of Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Either electronic or written comments on the collection of
information must be submitted by November 5, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 5, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-3675 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Pharmaceutical Distribution
Supply Chain; Drug Supply Chain Security.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="93c3c1d2c0e7f2f5f5d3f5f7f2bdfbfbe0bdf4fce5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance
[[Page 72849]]
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
OMB Control Number 0910-0806--Revision
This information collection helps support implementation of
sections 581 and 582 (21 U.S.C. 360eee and U.S.C. 360eee-1) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act), which govern the
pharmaceutical distribution supply chain. Definitions set forth in
section 581 of the FD&C Act prescribe specific activities that apply to
the individuals identified in section 582, including recordkeeping
requirements intended to effectuate the tracing of certain
pharmaceutical drugs as they are distributed within the United States.
The recordkeeping provisions expressly provided for in sections 582(b)
through (e) of the FD&C Act cover tasks associated with product
identification, product tracing, transaction data, record verification,
and disclosures (exchange) of information. Submissions to FDA, as
provided for in section 582, include making specific product
notifications, requesting exemption and/or waiver from any of the
statutory requirements, and requesting termination of a notification in
consultation with FDA.
The requirements of section 582 of the FD&C Act included in the
information collection are self-executing. We regard most of the
information collection activities required by the statute to be usual
and customary recordkeeping activities by respondents and have
therefore excluded from our estimated burden the time, effort, and
financial resources attributable to those activities consistent with 5
CFR 1320.3(b)(2). Additionally, we note that some respondents are also
subject to related reporting, recordkeeping, and disclosure
requirements applicable under the Controlled Substances Act, for which
currently active information collection approvals are maintained by the
Department of Justice's Drug Enforcement Administration. At the same
time, we account for notifications submitted to FDA, and estimate
recordkeeping burden attributable to activities corresponding with
illegitimate product notifications, including coordination of
investigations of suspect products, among trading partners, as required
by the statute.
To assist respondents with submitting specific product
notifications to FDA regarding illegitimate product and product with a
high-risk of illegitimacy, we have developed and utilize Form FDA 3911
entitled ``Drug Notification'' and the corresponding instructional
document ``INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911--DRUG
NOTIFICATION.'' Instruction regarding the submission of Form FDA 3911
using the Center for Drug Evaluation and Research ``NextGen'' portal is
available from our website at <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products</a>. Form FDA
3911 is intended to provide a uniform format for initial notifications,
followup notifications, and requests for the termination of a
notification. We believe followup activities regarding suspect and/or
illegitimate drug products includes information obtained during the
conduct of an official Agency investigation and thus not covered by the
PRA. Please see 5 CFR 1320.4(a)(2) and FDA ``General Enforcement
Regulations'' in 21 CFR part 1. We have revised Form FDA 3911, and the
instructions for completing the form, to add a new field requesting
information about the geographic location of the incident that is the
subject of the notification.
We have also published guidance documents, as provided for in
section 582 of the FD&C Act, developed specifically to facilitate the
efficient adoption of secure interoperable product tracing at the
package level by respondents. The guidance documents discuss the
recordkeeping activities expressly provided for in section 582 of the
FD&C Act. To date we have developed and issued the following guidance
documents:
<bullet> ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription
Drugs'' guidance (2023 Standards for Interoperable Exchange Guidance)
(September 6, 2023).
<bullet> ``Standardization of Data and Documentation Practices for
Product Tracing'' draft guidance (Standardization of Data Guidance)
(February 28, 2018).
<bullet> ``Enhanced Drug Distribution Security at the Package Level
Under the Drug Supply Chain Security Act'' guidance (Enhanced Drug
Distribution Security Guidance) (August 31, 2023).
<bullet> ``Verification Systems Under the Drug Supply Chain
Security [DSCSA] Act for Certain Prescription Drugs'' guidance
(Verification Guidance) (December 7, 2023).
<bullet> ``Definitions of Suspect Product and Illegitimate Product
for Verification Obligations Under the Drug Supply Chain Security Act''
guidance (Definitions Guidance) (March 16, 2023).
<bullet> ``Product Identifiers Under the Drug Supply Chain Security
Act--Questions and Answers'' guidance (Product Identifier Guidance)
(June 3, 2021).
<bullet> ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification'' guidance (Suspect
Product Guidance) (June 6, 2021).
<bullet> ``Waivers, Exceptions, and Exemptions from the
Requirements of Section 582 of the Federal Food, Drug, and Cosmetic
Act'' guidance (Waivers Guidance) (August 4, 2023).
All Agency guidance documents are issued in accordance with our
Good Guidance Practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable guidance database
on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that utilizes topic specific search terms.
We also maintain a web page at <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements</a> that communicates FDA's ongoing
implementation of the DSCSA requirements. Since DSCSA enactment on
November 27, 2013, FDA has established a public docket to receive
information and comments on DSCSA standards for the electronic tracking
system, including comments regarding paper and electronic formats of
information. In 2018, we initiated a pilot project, consistent with
section 582(j) of the FD&C Act and approved in OMB control number 0910-
0859, focusing on system attributes and demonstrating interoperability.
Since completion of the pilot project, we continue to focus on the
interoperability of the electronic systems described in section 582 of
the FD&C Act and have revised this information collection to capture
standardized transaction information.
Respondents to the information collection are manufacturers,
wholesale distributors, dispensers, and repackagers of pharmaceutical
drug products, as defined in section 581 of the FD&C Act and identified
in section 582(a)(1) of the FD&C Act. Based on Agency data, we assume
70,000 respondents: 1,230 manufacturers and 170 repackagers, (1,400
cumulatively); 1,600 distributors; and 67,000
[[Page 72850]]
dispensers (including online and chain pharmacies).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of Average time
21 U.S.C. 360eee-1(b)-(e); Number of responses per Total annual per response Total hours
information collection respondents respondent responses (in hours)
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Notifications of illegitimate 500 28.2 14,100 8 112,800
product: Form FDA 3911.........
Consultation/Requests for 500 1 500 1 500
termination of notification of
illegitimate product (Suspect
Product Guidance, sec. IV.B)...
Requests for waiver, exception 20 1 20 81 1,620
or exemption, including
material changes and renewals
(Waivers Guidance, sec. III)...
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Total....................... .............. .............. 14,620 .............. 114,920
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As reflected in table 1, reporting activities include the
submission of notifications to FDA regarding illegitimate product and
product with a high-risk of illegitimacy using Form FDA 3911. We
believe the burden that may be incurred from providing FDA with
followup information that may be necessary with regard to suspect and/
or illegitimate products is excluded from our accounting in accordance
with 5 CFR 1320.3(c) because such followup would entail reporting
activities that are usual and customary, and we have therefore not
included this activity in our estimate of burden. Reporting activities
also include requests for termination of a notification in consultation
with FDA, using Form FDA 3911. FDA may request any additional
information it determines necessary to complete the consultation.
Finally, an authorized trading partner or other stakeholder seeking a
waiver, exception, or exemption from requirements of section 582 of the
FD&C Act may submit a request to FDA, or a request for material changes
to or renewal of an approved initial request. These requests are also
included in the scope of reporting activities.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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21 U.S.C. 360eee-1(b)-(e); Number of Average burden
information collection Number of records per Total annual per record (in Total hours
activity respondents respondent records hours)
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Documenting transaction (T3) 70,000 1M 70,000,000,000 0.0000017 119,000
information.................
Disclosing illegitimate 500 620 310,000 6 1,860,000
product notifications and
terminations to trading
partners....................
Product identification & 1,400 3,125,000 4,300,000,000 0.00007 301,000
information exchange:
encoding packages and
homogeneous cases with
product identifier; exchange
of information only w/
authorized trading partners.
Verification: identify and 30,125 8 241,000 0.62 149,420
investigate suspect product,
coordinate with other
trading partners, quarantine
product, notify FDA of
suspect product that is not
determined to be
illegitimate product........
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Total.................... .............. .............. 74,300,551,000 .............. 2,429,420
(~74.3B)
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\1\ The recordkeeping requirement includes the requirement to retain, notify third parties, the Federal
government, or the public of the existence of such records; disclose such records to third parties, the
Federal government, or the public; or report to third parties, the Federal government, or the public regarding
such records. See 44 U.S.C. 3502(13); 5 CFR 1320.3(m).
\2\ We regard activities established in section 582(b)-(e) of the FD&C Act (21 U.S.C. 360eee-1(b)-(e)) to be
usual and customary for respondents to the information collection.
As reflected in table 2, the provisions in sections 582(b) through
(e) require ongoing recordkeeping that documents product
identification, tracing information, and verification activities.
Records are to be produced to FDA within 24 hours of a request,
consistent with section 582 of the FD&C Act. Each category of
respondent (manufacturer, distributer, wholesaler, repackager) may
expend varying degrees of time, effort, or financial resources to
generate, maintain, retain, notify, or disclose such records
commensurate with the corresponding tasks prescribed for that category.
Data elements required to be documented and disclosed are defined in
section 581 and set forth in section 582 of the FD&C Act. A significant
portion of recordkeeping activity pertains to product identification
and product tracing. Verification activities comprise another
significant portion of activity, where respondents expend time, effort,
or financial resources respective to their role. Although we have
quantified what we believe to be the average amount of time, effort, or
financial resources expended cumulatively by respondents, we regard
these recordkeeping activities as usual and customary and exclude them
from our burden estimate, consistent with 5 CFR 1320.3(b)(2).
Product Tracing and Product Identification
Information exchange activities with authorized trading partners as
contemplated by section 582 of the
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FD&C Act include: (1) providing the transaction information, the
transaction history (when applicable), and transaction statement (T3)
to the subsequent purchaser, providing relevant transaction
information, transaction history, and transaction statement upon a
request for information from FDA or other appropriate Federal or State
officials if a recall or investigation of suspect or illegitimate
product occurs, and, after the Statutory Date, facilitating the
gathering of information necessary to produce the transaction
information for each transaction \1\ going back to the manufacturer at
an authorized trading partner's request, or at the request of FDA or
other appropriate Federal or State officials; and (2) capturing and
maintaining transaction information, transaction history, and
transaction statements for each transaction for not less than 6 years
after the transaction. Product identification activities include the
requirement that manufacturers and repackagers affix or imprint a
product identifier to each package and homogeneous case of products
that they intend to be introduced in a transaction into commerce and
that they maintain product identifier information for each package and
homogeneous case of product for not less than 6 years.
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\1\ Transaction is defined in section 581(24) of the FD&C Act.
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Verification Activities
Verification activities include: (1) coordinating with other
trading partners during an investigation of a suspect product to
determine whether the product is illegitimate; (2) for manufacturers
and repackagers, responding to trading partners' requests for
verification of product identifiers; (3) maintaining records of suspect
product investigations and disposition of illegitimate product for not
less than 6 years; (4) identifying suspect product; (5) quarantining
suspect and illegitimate product; (6) investigating suspect product;
(7) notifying FDA of suspect product that is determined not to be
illegitimate product (when applicable); (8) processing saleable
returns; and (9) establishing systems and processes to comply with all
of these requirements.
We assume manufacturers, repackagers and wholesale distributors
will already have systems and processes to comply with many of these
requirements. Such systems will therefore only need to be updated to
ensure full compliance with the DSCSA. We also anticipate that a chain
pharmacy will develop the required systems and processes centrally at
its headquarters or at its distribution centers and then distribute to
each pharmacy.
Our estimated burden for the information collection as revised
reflects a significant decrease in the burden estimates for annual
responses and hours. We have excluded from our estimated burden the
time, effort, and financial resources attributable to those activities
we consider usual and customary by respondents, consistent with 5 CFR
1320.3(b)(2). We invite comment on our assumption.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20064 Filed 9-5-24; 8:45 am]
BILLING CODE 4164-01-P
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